Key Responsibilities
*Approve and schedule reports in the
Argus database
for submission to respective Health Authorities, as applicable.
*Submit cases to
Health Authorities, Business Partners, and Affiliates
as required.
*Ensure adherence to
internal and external timelines
for case processing to maintain regulatory reporting compliance.
*Schedule and approve regulatory reports based on
reporting obligations
.
Job Requirements
Years of Experience:
4–6 years of relevant experience in
Pharmacovigilance (PV)
, specifically in
ICSR Quality Review
and
Regulatory Report Submissions
.
Hands-on experience
with the
Argus Database
is essential.
Educational Qualification:
B.Pharm / M.Pharm
Skills and Competencies:
Strong knowledge of
PV regulations
and
guidelines
for Health Authority submissions.
Expertise in
quality assurance
and
compliance
.
Excellent
attention to detail
and
analytical skills
.
Strong
communication
and
time management
abilities.
